Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD guideline study. Read-across from strontium chromate. At the time of registration, the first audited draft of the study report was available (dated 2010-12-17). The owner company will receive the full study report as soon as it is completed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Strontium Chromate L203E obtained from SNCZ.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hypharm, La Corbiere, Roussay, France
- Age at study initiation: 2-4 months
- Weight at study initiation: 2.6 ± 0.1 kg
- Housing: individually in Techniplast cages (64x63x30 cm)
- Diet (e.g. ad libitum): pelleted diet "type 110C", batch no 10140 (SAFE, Augy, France) ad libitum
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 50 ± 20%
- Air changes (per hr): approx 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- No removal

SCORING SYSTEM: Chemosis score 0-4; redness score 0-3; discharge score 0-3, iris lesions score 0-2, opacity score 0-4; area of opacity score 1-4

TOOL USED TO ASSESS SCORE: UV-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
animal 546
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
animal 998
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
animal 999
Time point:
other: 24, 48, 72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
animal 546
Time point:
other: 24, 48, 72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
animal 998
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
animal 999
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
animal 546
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 2 days
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
animal 998
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
animal 999
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
animal 546
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
animal 998
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
animal 999
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Other effects:
A whitish area on the conjunctiva was observed in one animal on day 3.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Strontium chromate should not be classified as irritating to the eyes.
Executive summary:

The potential of strontium chromate to induce eye irritation was testing in rabbits according to the OECD guideline test 405. Slight or moderate eye irritation was observed, but according to the criteria of teh CLP regulation, the test item should not be classified as irritating to the eyes.